Columbia Laboratories, Inc. (Nasdaq: CBRX) and Watson Pharmaceuticals, Inc. (NYSE: WPI) announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Columbia's New Drug Application (NDA) for PROCHIEVE® (progesterone gel) for the reduction of risk of preterm birth in women...
Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced that it has submitted a formal appeal to the Office of New Drugs in the U.S. Food and Drug Administration's Center for Drug Evaluation and Research regarding the agency's decision from earlier this year on the pixantrone New Drug...
Pharmaceutical companies with good track records of approvals and first approvals are characterized not only by strong science but also strong working relationships with the FDA. Regulatory Affairs is the function that oversees and guides interactions with the FDA it's a job that comes with a...
Teikoku Pharma USA, Inc., an international specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for a new weekly transdermal patch of Aricept®, a leading medication for the treatment of Alzheimer's...
Elan Drug Technologies, a business unit of Elan Corporation, plc (NYSE: ELN) today issued the following statement regarding the U.S. Food and Drug Administration (FDA) approval of AMPYRA™ (dalfampridine) as a treatment to improve walking in patients with multiple sclerosis (MS). This was...
The Food and Drug Administration (FDA) has informed Photocure that the new drug application (NDA) for Hexvix for detection of non-invasive papillary bladder cancer may be approved pending approval of the PMA for the Karl Storz photodynamic diagnosis system and final agreements between Photocure...
CombinatoRx, Incorporated (NASDAQ: CRXX) and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has issued Neuromed a letter extending its review of the New Drug Application (NDA) for the product candidate Exalgo™...